ACRP CCRC ACTUAL TEST WITH REAL

ACRP CCRC ACTUAL TEST WITH REAL

QUESTIONS AND WELL VERIFIED ANSWERS ||

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Documents that may be inspected to show the sponsors oversight of trial may

include: - ANSWER-- Documents that describe transfer of obligations

• Investigator/site qualifications/selection process and training
• Monitoring plans, reports and corrective actions through the monitoring process

According to ICH E9, IDMCs should provide what? - ANSWER-- Intervals assess the safety of clinical trial

• Recommend to sponsor whether to continue, modify, or stop trial

What does NAI stand for? - ANSWER-No action indicated

What does VAI stands for? - ANSWER-Voluntary action indicated

What does OAI stand for? - ANSWER-Official action indicated

A report prepared by marketing-authorization holder describing the worldwide safety experience with medicine at defined time after authorization is called? - ANSWER-Periodic Safety Update Report (PSUR)

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Potential reasons for an unannounced clinical investigator inspection can include what? - ANSWER-- Receipt of complaint

• On termination of clinical site
• In response to sponsor or IRB/IEC inspections

Important immediate inspection preparation strategies include: - ANSWER--

Inform personnel

• Secure facility resources
• Organize study related documents
• Ensure access to original data

Directed/for-cause inspections may focus on? - ANSWER-The particular reason that prompted the inspection

What is the major focus area for routine inspections for a clinical investigator? - ANSWER-- Data reviews

• ICF process and documentation

What is the major focus area for a sponsor/CRO GCP inspection related to trial? - ANSWER-- Vendor selection and management

• Data management (e.g. review of data management plan)

Common inspection management strategies include? - ANSWER-- Scope of inspection

• Understand inspection timeframes

-Copy of personnel records

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What type of risk-based inspection involves the selection of a number of clinical trials for the inspection sample? - ANSWER-Routine National Systems Inspections

True or False? Globalization of clinical research is a major factor that's led to development of a common and accepted framework and sharing of inspection observations in different regions. - ANSWER-True

The FRD CDER published information about inspection site selection tools that takes into account what three levels of risk attributes? - ANSWER-Application level, study level, clinical site level

Factors that influence GCP inspection selection process include? - ANSWER-- The number of UK patients and nature of subjects

• Outcome of previous GCP inspections
• Organization with no inspection history

True or False? Concerns about accuracy of submitted data can include an unusual recruitment pattern. - ANSWER-True

True or False? For the EMA, inspections are conducted by the EMA inspectorate of the EU. - ANSWER-False

True or False? Comprehensive data management plans can help ensure the recording of accurate and complete data. - ANSWER-True

True or False? Regulatory investigators must have rights/privileges granted for electronic record systems. - ANSWER-True

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Current coordinator is asked a question about the enrollment source completed by prior coordinator during regulatory inspection. What should her response be if she knows the correct answer? - ANSWER-Decline answer as she has no first-hand knowledge of the creation of source document

Which are for full-analysis sample set? - ANSWER-- Includes all randomized subjects

• Complete follow-up of all randomized subjects for study outcomes if necessary
• Most likely to mirror normal day to day practice

Which are for a per-protocol sample set? - ANSWER-- Completion of pre- specified minimal exposure to treatment is necessary

• Availability of measurements of primary variable is necessary
• No major protocol violations nor violation of entry criteria

Investigator continues to randomize patient until patient is grouped with investigators desired product. Is this ethical? - ANSWER-No

Data manager suspects fraud and immediately calls investigator stating fraud was committed. Was this the best course of action? - ANSWER-No

What must or may the physician do with regard to unproven intervention?(Declaration of Helsinki) - ANSWER-May consider an unproved intervention What are expected or possible consequences of over-estimation of recruitment potential? - ANSWER-- The trial will overrun its projected timeline

• The recruitment period will be prolonged and more sites may be needed
• The study will not have sufficient data within the required timeframe and will be

stopped because of lack of budget

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